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FDA 510(k)

THE BODY COOLER SYSTEM

K-Number: K904998 · 1991-01-14

ApplicantCosta / French
Decision Date1991-01-14
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THE BODY COOLER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Costa / French. It received FDA 510(k) clearance on 1991-01-14 under 510(k) number K904998. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE BODY COOLER SYSTEM?

THE BODY COOLER SYSTEM is a medical device that received FDA 510(k) clearance on 1991-01-14. The listed applicant is Costa / French. The 510(k) number is K904998.

When did THE BODY COOLER SYSTEM receive FDA 510(k) clearance?

THE BODY COOLER SYSTEM received FDA 510(k) clearance on 1991-01-14, under 510(k) number K904998.

Who is the listed applicant for THE BODY COOLER SYSTEM?

The FDA 510(k) record lists Costa / French as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE BODY COOLER SYSTEM?

The FDA product code for THE BODY COOLER SYSTEM is ILO.

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Related Devices (Code: ILO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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